Roche Holding AG (ROG)’s Avastin failed to significantly extend the lives of older lung-cancer patients in a government-funded study, raising questions about whether the treatment should be given to U.S. Medicare enrollees.
Patients aged 65 and older who received Avastin in addition to a standard chemotherapy regimen had a median overall survival of 9.7 months, according to the study to be published tomorrow in the Journal of the American Medical Association. While that was longer than the 8.9 months and 8 months for two groups of patients receiving chemotherapy only, the finding wasn’t statistically significant, said the researchers from the Dana- Farber Cancer Institute in Boston.
Avastin, a $5.8 billion-a-year product also known as bevacizumab, won U.S. Food and Drug Administration approval for non-small cell lung cancer in 2006, after a study found the therapy improved survival by a median of two months. That research showed no benefit among patients aged 65 and older, who are covered by Medicare, the government health-insurance program for the elderly and disabled. At least two-thirds of patients with lung cancer qualify for Medicare, which has covered Avastin for that use since FDA approval, the authors said.
“Clinicians should exercise caution in making treatment recommendations and should use bevacizumab judiciously for their older patients,” the researchers wrote. About 22 percent of patients diagnosed with the disease in 2007 were given Avastin as part of their first-line chemotherapy, suggesting the product’s adoption “was by no means universal,” they said.
Guidelines from National Comprehensive Cancer Network and the European Society of Medical Oncology recommend Avastin plus chemotherapy as a treatment option for lung cancer, Basel, Switzerland-based Roche said in an e-mailed statement.
Avastin “was the first to help people live longer than one year” in a large study, Roche said.
The Dana-Farber researchers examined data from 4,168 Medicare enrollees who were diagnosed with advanced non-squamous non-small cell lung cancer between 2002 and 2007. The patients were divided into three groups: those who received Avastin as part of their treatment, those who had chemotherapy alone between 2006 and 2007, and those treated with chemotherapy alone in 2002-2005, before Avastin won U.S. approval for lung cancer.
Patients in the Avastin group had a 39.6 percent probability of surviving one year, compared with 40.1 percent getting chemotherapy from 2006-2007 and 35.6 percent for those treated earlier than 2006, the study found. More recent data might yield different results, the researchers said.
Only 318 of the 4,168 records used in the study were from people who received Avastin, Roche said. That imbalance skews the results to favor longer survival times for patients who didn’t get Avastin, the company said.
The government should consider requiring drugmakers to include a significant number of elderly patients in studies of treatments intended to be used against tumors that appear mainly in older people, the study’s authors said.
Roche agreed that older patients usually aren’t well represented in studies. The company said it collects information on the use of medicines after approval through large observational studies. In one such study of 1,970 lung-cancer patients who took Avastin, the median survival was 13.6 months, Roche said. About one-third of the participants were age 70 or older, and the median survival for that group was 12.6 months, the company said.
Avastin, developed by Roche’s Genentech unit, works by blocking blood-vessel growth and choking off the supply of nutrients that tumors need to thrive. The therapy had 1.39 billion francs ($1.5 billion) in first-quarter sales, Roche said last week.
The FDA in November revoked approval of Avastin as a treatment for metastatic breast cancer, saying the drug didn’t extend lives and triggered side effects including high-blood pressure and bleeding when used for the disease.
The U.S. Agency for Healthcare Research and Quality and the National Cancer Institute funded the Dana-Farber study.
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